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Prostate CancerNCT03889119

Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer

A study testing Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System. in people with Prostate Cancer, run by Hoag Memorial Hospital Presbyterian at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to learn the long term efficacy and side effects associated with utilizing Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System. SBRT uses advanced imaging techniques to deliver targeted radiation to a tumor. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System.
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
21 Oct 2016to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of adenocarcinoma of the prostate History/physical examination with digital rectal examination of the prostate
  • Histological evaluation of prostate biopsy with assignment of Gleason score to the biopsy material.
  • Clinical stage T1-3 (AJCC 7th edition).
  • Males age ≥ 18
  • Patient must be able to provide study-specific informed consent prior to study entry.
  • Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire

Who cannot join

  • Evidence of distant metastases
  • Regional lymph node involvement
  • Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer
  • Previous pelvic irradiation, prostate brachytherapy
  • Previous or concurrent cytotoxic chemotherapy for prostate cancer
  • There are no exclusions due to co-morbid disease or illnesses except for patients with severe inflammatory bowel disease
  • No life expectancy restrictions will apply
  • Performance Status will not be considered

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Hoag Memorial Hospital Presbyterian

    Irvine, California, 92618

Other trials in United States

About this study

Official title: Stereotactic Body Radiation Therapy (SBRT) for the Management of Carcinoma of the Prostate: Quality of Life Data After Primary Stereotactic Body Radiation Therapy for Localized Prostate Cancer

The purpose of this study is to learn the long term efficacy and side effects associated with utilizing Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System. SBRT uses advanced imaging techniques to deliver targeted radiation to a tumor. The Elekta Versa and Agility Systems are approved by the Food and Drug Association (FDA) for SBRT treatment of cancer.

Traditional External beam radiation therapy (EBRT) for prostate carcinoma is typically done over the course of approximately 42-45 daily treatments SBRT is a way to condense this treatment into a course of 5 treatments, delivering more dose per day.

Read the detailed description

Prostate cancer is the most common cancer diagnosed in men, and ranks second in estimated deaths. The current standard of care for localized prostate cancer consists of observation, surgery or radiation therapy. From a radiation perspective, accepted options include external beam radiation therapy, brachytherapy, or a combination of those. Acceptable external beam radiation options are further defined as conventionally fractionated (over approximately 8-9 weeks), or moderately hypo-fractionated (over approximately 4-6 weeks).

Stereotactic body radiation therapy (SBRT) is a newer technique, allowing treatment to be delivered in an extremely hypo-fractionated regimen (i.e. in 5 fractions). Current consensus guidelines describe SBRT as "a cautious alternative to conventionally fractionated regimens at clinics with appropriate technology, physics, and clinical expertise."

The goal of any therapy is to maximize the effect of that treatment on cancer cells and minimize any effect on normal tissue. In radiation therapy, this is mainly done through dose targeting (i.e. limiting the radiation dose to the targets and minimizing dose to normal surrounding organs). Advancements in radiation therapy have allowed for better targeting, resulting in shrinking margins of treatment around cancer cells.

The therapeutic window can also be optimized through the use of fractionation (i.e. amount of dose delivered per day) in radiation therapy. Since cancerous and normal tissue cells respond differently to changes in fractionation, the therapeutic window could theoretically be improved by choosing a fractionation pattern to which cancer cells are more sensitive. Historical generalizations put cancer cells into the category of early responding tissues, which would make them more sensitive to cell death when radiation is delivered in a protracted fractionation pattern, such as over 8-9 weeks of radiation therapy.

However, studies have emerged which suggest that prostate cancer is unlike other cancers and reactive more like late responding tissues. With that in mind, prostate cancer cells could be more sensitive to high doses per fraction, which could provide a radiobiological advantage and a greater therapeutic window with the use of SBRT.

Very promising early results utilizing SBRT for prostate cancer treatment have been described in the literature, and multiple ongoing phase 3 trials are underway.

Aside from a potential therapeutic advantage, SBRT also offers a more cost effective solution to patients with prostate cancer, with less impact on their daily lives (only needing to come in for 5 treatments instead of 40-45 treatments).

Much of the literature on SBRT has been done utilizing the CyberKnife system. But the Elekta Versa HD and Agility Systems available at Hoag provides a unique opportunity for faster treatment delivery and 4D imaging during treatment. The Elekta Versa HD and Agility systems are approved by the FDA for SBRT treatment of cancer.

This study seeks to investigate biochemical failure rates for patients treated with SBRT utilizing Elekta machines, as well as obtain quality of life data and assess the intrafraction motion in approximately 15 patients for 5 years following SBRT.

Conditions
Prostate Cancer
Being tested
Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System.
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System.Radiation

    Also called Cyberknife

    SBRT uses advanced imaging techniques to deliver targeted radiation to a tumor. The Elekta Versa and Agility Systems are approved by the Food and Drug Association (FDA) for SBRT treatment of cancer.

Study groups in NCT03889119
Study groupRoleWhat they receive
Elekta Versa HDActive comparatorThis study seeks to investigate biochemical failure rates for patients treated with SBRT utilizing Elekta machines, as well as obtain quality of life data and assess the intrafraction motion in approximately 15 patients for 5 years following SBRT.
Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System.
Agility SystemsOtherThis study seeks to investigate biochemical failure rates for patients treated with SBRT utilizing Agility Systems, as well as obtain quality of life data and assess the intrafraction motion in approximately 15 patients for 5 years following SBRT.
Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary aim of this study is to examine biochemical failure rates after SBRT for patients with low, intermediate, and high risk localized non-metastatic prostate cancer.

    The number of patients demonstrating biochemical failure will be assessed. Biochemical failure will be defined using the Phoenix definition (Roach et al. IJROBP 2006), which is defined as a rise above nadir PSA + 2 ng/ml.

    Measured: 5 years

Secondary outcomes (1)
  1. The secondary aim is to obtain quality of life data to examine the potential complications associated with SBRT: detailed symptom questionnaire

    Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) (Chang J Urol 2011) total symptom score change from baseline will be assessed. This total score ranges from 0-60, with higher scores representing more symptoms.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2019
  2. Study start21 Oct 2016
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
SBRT for the management of localized prostate cancer is a Phase II non-randomized clinical trial open to patients with biopsy proven localized prostate cancer. Patients will be deemed eligible for SBRT in any risk group categorization based upon the standard D'Amico stratification: * Low-risk: initial PSA \<10 and clinical stage T1c-T2a/b and biopsy Gleason grade 3+3 * Intermediate-risk: initial PSA \>10 but \<20 or clinical stage T2c or biopsy Gleason grade 3+4 or 4+3 * High-risk: initial PSA \>20 or clinical stage T3 or biopsy Gleason grade 4+4 or higher).
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03889119
Sponsor's protocol ID
115-16-CA
Status last verified
Mar 2025
First submitted
19 Mar 2019
Last updated
15 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System. in people with Prostate Cancer, run by Hoag Memorial Hospital Presbyterian at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary aim of this study is to examine biochemical failure rates after SBRT for patients with low, intermediate, and high risk localized non-metastatic prostate cancer. (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.

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